Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate; potassium clavulanate
Dechra Regulatory B.V.
QJ01CR02
Amoxicillin trihydrate; potassium clavulanate
200, 50 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
amoxicillin and enzyme inhibitor
Authorised
2011-04-15
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clavudale 200 mg/50 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Amoxicillin (as amoxicillin trihydrate) 200 mg Clavulanic acid (as potassium clavulanate) 50 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Erythrosine (E127) 3.75 mg Silica, colloidal anhydrous - Magnesium stearate - Sodium starch glycolate (Type A) - Cellulose, microcrystalline - Luctarom 31600z additive (meat flavour) - Pink, oblong, scored tablets. The tablet can be divided into halves. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of bacterial infections susceptible to amoxicillin in combination with clavulanic acid where clinical experience and/or sensitivity testing indicates the veterinary medicinal product as the drug of choice. Uses include: Skin infections (including deep and superficial pyodermas) associated with _Staphylococcus_ spp. and _Streptococcus_ spp.; Infections of the oral cavity (mucous membrane) associated with _Clostridium_ spp., _Trueperella_ spp. (previously _Corynebacterium_ spp.), _Staphylococcus_ spp., _Streptococcus_ spp., _Bacteroides_ spp. and _Pasteurella_ spp; 2 Urinary tract infections associated with _Staphylococcus_ spp., _Streptococcus_ spp., _Escherichia coli _ and _Proteus mirabilis;_ Respiratory tract infections associated with _Staphylococcus_ spp., _Streptococcus_ spp., and _Pasteurella_ spp. Gastrointestinal infections associated with _Escherichia coli_ and _Proteus_ _mirabilis_ . 3.3 CONTRAINDICATIONS Do not use in rabbits, guinea pigs, hamsters and gerbils. Do not use in cases of hypersensitivity to the active substances, substances of the β-lactam group or to any of the excipients. Do not use in animals with either oliguria or anuria associated with renal dysfunction. Do not use in c Прочитайте повний документ